Medications & Supplements/Prescription Drugs

Cipla and Exelan Lanthanum Carbonate Tablets Recalled for Broken Tablets

Agency Publication Date: November 12, 2024

Summary

Cipla USA, Inc. is recalling 1,875 boxes (cipla and exlan) of Lanthanum Carbonate Chewable Tablets, 1000mg, after receiving complaints of crushed and broken tablets inside the bottles. The recall affects 10-count prescription bottles sold under both the Cipla USA and Exelan Pharmaceuticals brands. These tablets are used to control phosphate levels in patients with chronic kidney disease, and damaged medication can compromise treatment.

Risk

Broken or crushed tablets can lead to an incorrect dosage being administered, which may cause ineffective management of phosphate levels in patients. No injuries have been reported to date, but the medication's physical integrity failed to meet manufacturing specifications.

What You Should Do

This recall affects 10-count bottles of Lanthanum Carbonate Chewable Tablets, 1000mg, sold under the Cipla USA and Exelan Pharmaceuticals brands.
To identify if your product is affected, check for NDC 69097-0936-98 (Cipla USA) with lot number NB240316 and expiration date 12/31/25, or NDC 76282-0478-90 (Exelan Pharmaceuticals) with lot number NB240873 and expiration date 03/31/2026.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lanthanum Carbonate Chewable Tablets (1000mg, 10-count bottle)by Cipla USA

Variants: 1000mg, Chewable Tablet, 10-count bottle

Lot Numbers:

NB240316 (Exp 12/31/25)

NDC:

69097-0936-98

Manufactured for Cipla USA; Recall #: D-0043-2025

Product: Lanthanum Carbonate Chewable Tablets (1000mg, 10-count bottle)by Exelan Pharmaceuticals

Variants: 1000mg, Chewable Tablet, 10-count bottle

Lot Numbers:

NB240873 (Exp 03/31/2026)

NDC:

76282-0478-90

Manufactured for Exelan Pharmaceuticals; Recall #: D-0044-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95611

Status: Active

Manufacturer: Cipla USA, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 1,875 boxes (cipla and exlan)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 10-count bottles of Lanthanum Carbonate Chewable Tablets, 1000mg, sold under the Cipla USA and Exelan Pharmaceuticals brands.

To identify if your product is affected, check for NDC 69097-0936-98 (Cipla USA) with lot number NB240316 and expiration date 12/31/25, or NDC 76282-0478-90 (Exelan Pharmaceuticals) with lot number NB240873 and expiration date 03/31/2026.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lanthanum Carbonate Chewable Tablets (1000mg, 10-count bottle)by Cipla USA

Variants: 1000mg, Chewable Tablet, 10-count bottle

Lot Numbers:

NB240316 (Exp 12/31/25)

NDC:

69097-0936-98

Manufactured for Cipla USA; Recall #: D-0043-2025

Product: Lanthanum Carbonate Chewable Tablets (1000mg, 10-count bottle)by Exelan Pharmaceuticals

Variants: 1000mg, Chewable Tablet, 10-count bottle

Lot Numbers:

NB240873 (Exp 03/31/2026)

NDC:

76282-0478-90

Manufactured for Exelan Pharmaceuticals; Recall #: D-0044-2025